Propofol Pharmacokinetics in Children After Single Bolus Dose

Post Graduate Institute of Medical Education and Research, Chandigarh12 enrolled

Overview

The principle objective of this study is to evaluate pharmacokinetics of propofol after single iv bolus dose in 12 Indian children and to develop a simple pharmacokinetic model of propofol.

PROPOFOL is the most suitable agent currently available for induction and maintenance of anesthesia. So far, the pharmacokinetics of propofol has not been studied in Indian children. We believe that this pharmacokinetic characterization of propofol will help in better management of these patients undergoing surgery under total intravenous anesthesia (TIVA) in our setup. 12 ASA (American Society of Anesthesiologists) grade I patients, 5 to 12 years old planned for elective surgery will be included. Premedication will be done with syrup midazolam 0.5mg/kg. After shifting the patient to the operation table, routine physiological monitoring will be commenced and two intravenous lines will be secured,one in the antecubital vein of one arm and the other vein on the dorsum of the contralateral hand. The antecubital venous access will be used for blood sampling. Anesthetic technique will consist of fentanyl bolus dose of 2ug/kg followed by propofol bolus dose of 2.5 mg/kg. No further propofol will be administered. After loss of consciousness , patients will be paralysed with atracurium (0.5mg/kg) and endotracheal intubation will be performed. Anesthesia will be maintained with isoflurane, oxygen (50%) and nitrous oxide (50%), and intermittent dosages of atracurium. A total of twelve samples will be collected from each patient at 0, 2, 4, 6, 10, 20, 30, 60, 90, 120, 240, and 480 min after administration of bolus dose of propofol.The samples will be analyzed using a modified High Performance Liquid Chromatography method described by Pavan et al. The pharmacokinetic parameters will be evaluated using three compartment model to develop a pharmacokinetic model by using the software WINNONLIN (Windows Non Linear Regression Program).

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Propofol Pharmacokinetics

Interventions

PropofolDRUG

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged 5-12 years and ASA (American Society of Anesthesiologists) grade I, planned for elective surgery under general anesthesia Exclusion Criteria:entered * Allergic history to one of the constituents of propofol * Any evidence of cardiovascular, respiratory,metabolic ,renal ,hematologic,hepatic or central nervous system disease * Previous adverse anesthetic events * Potential airway management problems

Locations (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Outcomes

Primary Outcomes

Plasma Propofol concentration

Time frame: 0, 2, 4, 6, 10, 20, 30, 60, 90, 120, 240 and 480 minutes post loading dose of Propofol

Data from ClinicalTrials.gov

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